Most new chemical entity medicines to-day are biological in origin. Due to the inherent variability of biological systems, the concept of biosimilar medicines rather than multisource/generic biological medicines is applied by health authorities’ worldwide. This one day targeted training focuses on meeting the requirements for registration of a Biosimilar Medicine.
- Registration of Biosimilar Medicines
- What must be studied and compared
- Process of doing a comparability study
- Case Study
- Issues you are likely to encounter